The Draft Order of the Russian Ministry of Healthcare on multiagency commission on the detection of medicines shortage or a risk of shortage was published on the official website for draft regulatory acts.
As we have written previously, Federal Law No. 46 “On Amending Certain Legislative Acts of the Russian Federation” suggested considerable changes in regulations of the pharmaceutical sphere that are aimed at prevention of medicines shortage or a risk of shortage.
The Draft Order was presented in compliance with para. 2 of the Government Decree No. 593 of 5 April 2022 “On the features of circulation of medicines in case of shortage or a risk of shortage as a result of enforcement of economic sanctions against Russian Federation”.
The multiagency commission will include, among others, representatives of the Ministry of Industry and Trade, the Ministry of Finance, Federal Customs Service, Federal Service for Supervision in Healthcare (Roszdravnadzor) and Federal Antimonopoly Service.
According to the Draft Order the main objectives of the multiagency commission are detection of medicines shortage and providing a decision on the possibility of import and circulation of foreign medicines batches.
For instance, the positive decision on the shortage can be made because of exit of the product manufacturer or supplier from the Russian market or medicines registration cancellation. The list of circumstances that may lead to the positive decision on the shortage is not exhaustive.
The information on the medicines shortage or a risk of shortage will be provided by the federal executive authorities, executive authorities of the Russian Federation constituents and other authorities concerned with the circulation of medicines.
The Draft Order establishes other organizational provisions on the multiagency commission activity. Moreover, the Draft Order is going to provide model templates of multiagency commission decisions.